D-0338-2021 Class III Terminated
FDA drug recall D-0338-2021 was initiated by Teligent Pharma, Inc. on February 2, 2021 and is designated Class III. Reason for recall: Failed Impurities/ Degradation Specifications - OOS for know impurity Betamethasone 17- propionate. The recall status is terminated (terminated August 15, 2024). Affected quantity: 104,784 tubes.
Recall Details
- Product Type
- Drugs
- Report Date
- May 5, 2021
- Initiation Date
- February 2, 2021
- Termination Date
- August 15, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 104,784 tubes
Product Description
Betamethasone Dipropionate Ointment USP, 0.05% (Augmented), packaged in 15 grams tubes, Manufactured by: Teligent Pharma, Inc. Buena, New Jersey 08310, NDC 52565-019-15
Reason for Recall
Failed Impurities/ Degradation Specifications - OOS for know impurity Betamethasone 17- propionate.
Distribution Pattern
USA Nationwide
Code Information
Lot #: 14297, Exp 9/2021; 15372, Exp 3/2022; 15841, Exp 8/2022